Clinical Guard

GUDID 00897429002766

Clinical Guard

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

• Primary Device ID: 00897429002766
• NIH Device Record Key: 148c8c4e-c35f-4db9-97d3-cbb8eb4711c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clinical Guard
• Version Model Number: Ovulation Urine Test Strip Pack of 50
• Company DUNS: 827033924
• Company Name: Clinical Guard
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851950008093 [Unit of Use]
GS1	00897429002766 [Primary]
GS1	10897429002763 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2017-12-19

On-Brand Devices [Clinical Guard]

• 10897429002978: CMS50F
• 20897429002524: CMS 50DL
• 00897429002476: Aero2
• 20897429002463: CMS500S
• 10897429002237: CMS50E
• 00897429002766: Ovulation Urine Test Strip Pack of 50
• 10897429002701: LH40 and HCG 10 Combo
• 00897429002513: Sonoline B